Senior Validation Engineer — cGMP, Life Sciences QA

Gertek Project Management; Sligo; On-site; EUR 65,000 - 90,000; Full time

Job summary

GerTEK is seeking a Validation Engineer to support validation programs across equipment, utilities and processes within a life science manufacturing context. The role involves creating and executing validation plans, protocols and reports in line with cGMP standards.

You will assist with investigations, CAPAs and change control while coordinating vendor activities and ensuring training and continuous improvement within the team.

Qualifications

• Relevant degree and 5 years' experience.
• Autoclave validation execution experience (preferred).
• Aseptic processing validation including media fills and VHP validation execution (preferred).
• HVAC validation (preferred).

Responsibilities

• Active participation in the Validation Program and QA activities.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• QA support for validation investigations and corrective actions.
• Vendor supervision for validation activities.
• Execution of Autoclave, Parts washer, Lyo, CIP and SIP, VHP and Temperature Mapping for validation needs.
• Creation/Review/Approval of validation documents; management of validation, exceptions, and change control.
• Documenting all activities in line with cGMP requirements.
• Cross training within the team and training of new members.
• Participation in continuous improvement programs to enhance manufacturing, quality, safety and training systems.

Skills

Validation

Quality Assurance

cGMP

GAMP

Education

Relevant degree

Tools

Autoclave

Media fills

VHP validation

HVAC validation

Job description

GerTEK is seeking a Validation Engineer to support validation programs across equipment, utilities and processes within a life science manufacturing context. The role involves creating and executing validation plans, protocols and reports in line with cGMP standards.

You will assist with investigations, CAPAs and change control while coordinating vendor activities and ensuring training and continuous improvement within the team.